4.2 National Drug Policy and Essential Drugs List

Of the 15 countries assessed, Benin, Kenya, Malawi, Myanmar, Tanzania, Tunisia, and Yemen have written and approved national drug policies covering aspects related to drug regulatory control, registration, procurement and quality assurance. A plan for the implementation of the drug policy exists in Benin, Ecuador, Malawi, Tanzania, Tunisia, and Yemen.

In those countries where a written and approved drug policy does not exist, one or more elements of a national drug policy e.g. regulatory control, drug registration, drug procurement, and quality assurance are being implemented. Similarly, all countries recognize the importance of an essential drugs list and use these lists for procurement in the public sector. The number of drug substances in the national lists varied from 120 to 670.

Table 2 shows the existence of a national drug policy, essential drugs list and drug legislation.

Table 2. Existence of national drug policy, national essential drugs list and legislation

* A written and approved national policy covering all aspects related to drug regulatory activities exists.

** Written national drug policy does not exist as such but elements of a national drug policy are being implemented.

*** A national drug policy entitled “The Kenya National Drug Policy” was adopted in July 1994.

Drug legislation exists in all the countries except in Central African Republic where it was in the process of being developed at the time of the mission. Specific regulations relating to drug registration exist in Benin, Cameroon, Ecuador, Jamaica, Kenya, Malawi, Malaysia, Sri Lanka, Tanzania, Tunisia, and Yemen, while Malaysia, Tanzania, and Tunisia also have specific regulations relating to drug quality.